Calendar

pharmadog

Week of Mar 9, 2026

Mar 10, 2026device 510k159d agoSynthes GmbH — DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System (510k cleared)

Advisory committee: Unknown. Type: Traditional

full page →fda device 510k ↗

Mar 10, 2026device 510k159d agoFUJIFILM Sonosite, Inc. — Sonosite iLOOK Ultrasound System (510k cleared)

Product code: IYN. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Mar 10, 2026device 510k159d agoInstitut Straumann AG — Straumann® BLC Implants - Indication Widening (510k cleared)

Product code: DZE. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Mar 10, 2026device 510k159d agoReselute, Inc. — Reselute Tibial Nail (510k cleared)

Product code: HSB. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

Mar 10, 2026device 510k159d agoCefla S.C. — myray ProXIma X6 (510k cleared)

Product code: OAS. Advisory committee: Radiology. Type: Traditional

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Mar 10, 2026device 510k159d agoCanon Medical Systems Corporation — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (510k cleared)

Product code: OWB. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Mar 10, 2026device 510k159d agoNakanishi, Inc. — Varios Combi Pro2 (510k cleared)

Product code: ELC. Advisory committee: Dental. Type: Traditional

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Mar 10, 2026device pma159d agoBoston Scientific Corp — REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (PMA)BOSTON SCIENTIFIC CORP

Product code: MAF. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Mar 10, 2026device pma159d agoBard Peripheral Vascular, Inc. — LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM (PMA supplement)

Supplement type: Real-Time Process. Product code: NIP. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Mar 10, 2026device pma159d agoBiotronik, Inc. — Astron Pulsar Pulsar-18, Pulsar-18 T3 (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Mar 10, 2026device pma159d agoVistakon, Johnson & Johnson Vision Products, Inc. — VISTAKON® (etafilcon A) lenses (PMA supplement)JOHNSON & JOHNSON

Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30

full page →fda device pma ↗

Mar 10, 2026device pma159d agoMyriad Genetic Laboratories, Inc. — MyChoice® CDx (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: PJG. Advisory committee: PA. Decision: APPR

full page →fda device pma ↗

Mar 10, 2026device pma159d agoBiotronik, Inc. — Astron (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIO. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Mar 10, 2026device pma159d agoCardiovascular Systems, Inc. — Diamondback 360 Coronary Orbital Atherectomy System; Diamondback 360 Precision Coronary Orbital Atherectomy System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MCX. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Mar 10, 2026device recall159d agoSiemens Medical Solutions USA, Inc device recall (Cls II)

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. — Reason: During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements. — Status: Ongoing

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Mar 10, 2026grant159d agoUNIVERSITY OF TENNESSEE HEALTH SCI CTR — Extended amygdala somatostatin role in post-traumatic stress and alcohol use ...

AA grant. $249,000. PI: Bryan Cruz

Week of Mar 9, 2026